Automated Robotic TCD in Traumatic Brain Injury

Brain Injuries, Traumatic Clinical Trial

— ART-TBI  

Official title:

Automated Robotic TCD in Traumatic Brain Injury (ART-TBI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848297
• Other study ID #: HM20026297
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Virginia Commonwealth University
• Contact: Shraddha Mainali, MD
• Phone: (804) 828-5269
• Email: shraddha.mainali[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience

Description:

Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.

Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for >= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period

Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults =18

• Blunt TBI with Glasgow Coma Score (GCS) =8

• Injury within 72 hours

• Adequate TCD windows

• Ability to obtain informed consent from a Legally Authorized Representative (LAR)

Exclusion Criteria:

• Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)

• C- spine fracture with evidence of spinal cord injury

• Severe skull or scalp injury precluding device placement

• Planned decompressive hemicraniectomy

• Continuous fever for >6 hours at the time of enrollment (despite treatment)

• Lack of TCD window

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Device:
• Transcranial Doppler ultrasonography (TCD)
Portable, bedside, non-invasive diagnostic tool used for real-time assessment of cerebral hemodynamics

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	University of California, Davis, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient discomfort (per discretion of the bedside nurse)	To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Bedside nurse will describe	2 years
Primary	Inadvertent dislodgement of other intracranial monitoring device/s (if present)	To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe	2 years
Primary	Skin changes associated with TCD	To evaluate the safety of prolonged automated robotic TCD monitoring in severe TBI population. Provider filling out form will describe	2 years
Primary	Provider feedback on safety of prolonged automated robotic TCD monitoring in severe TBI population.	A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety of protocol implementation.	2 years
Primary	Evaluation of adequate temporal windows	To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe	2 years
Primary	Evaluation of adequate insolation of middle cerebral arteries (MCA)	To evaluate the feasibility of prolonged automated robotic TCD monitoring in severe TBI population. Provider completing form will describe	2 years
Primary	Provider feedback on the feasibility of prolonged automated robotic TCD monitoring in severe TBI population	A 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived feasibility of protocol implementation, as well as other limiting factors. The survey will be in the format of a Likert scale.	2 years